Sheena McKie
Clayton Utz
Special Counsel
Sydney
Recognised as a Rising Star in Product Liability
– Rising Stars Awards Asia-Pacific, IFLR
Overview
Sheena is an experienced commercial litigator, having advised on some of Australia's most high-profile, large-scale class actions, complex commercial and product liability litigation. She has a broad-ranging regulatory and advisory practice relating to all types of products, with a particular focus on the healthcare and life sciences sector, involving pharmaceutical and medical devices.
Notable Work
- Johnson & Johnson Medical Pty Ltd, Ethicon Sàrl and Ethicon, Inc.: acts in two class actions in the Federal Court concerning pelvic mesh medical devices.
- Philips Electronics Australia Ltd and Philips RS North America LLC: acts in a class action relating to named CPAP and BiPAP devices for the treatment of sleep apnoea, which are also the subject of a global recall, which began in mid-2021, and associated regulatory investigations.
- Jaguar Land Rover Australia Pty Ltd: acts in a class action about the diesel particulate filters in diesel combustion engines.
- Volkswagen Group Australia Pty Ltd: acted successfully in a class action relating to the Takata airbag recall (affirmed on appeal).
- App platform: acting in class action proceedings commenced on behalf of consumers and developers seeking compensation arising from alleged overpayments on in-app purchases.
- Merck & Co., Inc. and Merck Sharp & Dohme (Australia) Pty Limited: acted successfully in a class action in the Federal Court concerning VIOXX, a prescription medicine.
- Novartis Pharmaceuticals Australia Pty Ltd: acted in litigation against the Department of Health over the Minister's refusal to exercise discretion to reverse a price reduction.
- Local and international companies: advises about strategy and legal issues relating to pricing and reimbursement for pharmaceutical products, specifically the Pharmaceutical Benefits Scheme and regulatory pricing frameworks.
- Australian and overseas clients: acts in product regulatory, product safety and recall issues under the Australian Consumer Law, including regulatory liaison and recall implementation for products including therapeutic goods (medicines and medical devices), animal health products, food, cosmetics and other consumer goods, and novel products.
- Local and international companies: advises on how to address class action risk in the context of corporate mergers and acquisitions.
Insights
TGA enforcement actions rise as Court orders the biggest Therapeutic Goods Act penalty yet
4 Nov 2024 | Article
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International Comparative Legal Guide - Pharmaceutical Advertising 2024
8 Aug 2024 | Document
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Statutory price reduction of pharmaceutical items and applying the 12.5% Test
11 Jul 2024 | Article
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International Comparative Legal Guide - Pharmaceutical Advertising Australia 2023
23 Aug 2023 | Document
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High Court ruling on foreign residents as group members in Australian class actions raises practical issues for respondents
12 Oct 2022 | Article
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Advertisers beware! New changes set to shake up Australian therapeutic goods advertising
3 Feb 2022 | Article
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Protecting or creating a stumbling block for future class members: proposed reforms to litigation funding payouts
11 Nov 2021 | Article
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COVID-19 Vaccination Information Distillation 3: COVID-19 vaccine claims scheme introduced for claims of $5,000 or more
16 Sep 2021 | Article
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COVID-19 Vaccination Information Distillation 2: New vaccines, regulation and a Commonwealth indemnity scheme
2 Sep 2021 | Article
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COVID-19 Vaccination Information Distillation: TGA's registration process for the COVID-19 vaccine and what to consider now
13 May 2021 | Article
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Reforming Australia’s litigation funding and class actions 05: the benefits of a nationally uniform class action system
13 May 2021 | Article
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Practical Law Country - Product liability and safety in Australia
2 Nov 2020 | Document
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Door (re)opened for disappointed tour groups: High Court paves way for group member compensation
14 May 2020 | Article
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$10m penalty for prescription-only advertisements by supplements retailer: TGA gets tough on suppliers
8 Aug 2019 | Article
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TGA spotlight on medical devices – consultation periods close soon
7 Feb 2019 | Article
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Mandatory reporting of shortages of prescription medicines comes in soon - but still some queries about what sponsors must do
25 Oct 2018 | Article
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Law Business Research Product Regulation and Liability Review Australia - 2017
30 Jun 2017 | Document
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